Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lambdalina (lidocaine cream) versus placebo as an anesthetic for laser hair removal

Conditions: Local Anesthesia

Summary: double-blind, randomized, placebo-controlled trial to assess the efficacy of lambdalina (lidocaine cream) in reducing pain associated with laser hair removal in women.


Eligibility criteria:
inclusion criteria: 1. women ≥ 18 and ≤ 65 years old. 2. laser hair removal treatment session in the legs in the area from the knee to the ankle (first or second application). 3. able of accomplishing the study's requirements. 4. negative result in the pregnancy test. 5. sterile or surgically sterilized women (hysterectomy, tubal ligation) or using adequate contraceptive methods. 6. written informed consent prior to inclusion in the trial. exclusion criteria: - general exclusion criteria: 1. pregnant or breastfeeding. - current or previous medical conditions: 2. skin type 5 or 6 or a history of photosensitivity. 3. cardiovascular diseases such as unstable angina, or severe heart failure (new york heart association iii or iv). 4. neuropathy or paresthesia. 5. history of hepatic failure. 6. autoimmune diseases. 7. allergies to peanuts and/or soy and/or any components of the formulation. 8. use or dependence on prohibited substances. 9. other contraindications specified in the summary of product characteristics. - current or previous concomitant medications: 10. any anesthetic or analgesic treatment during 2 hours prior of study entry. 11. concomitant treatment with antiarrhythmic drugs of class i (eg. tocainide, mexiletine) or class iii (eg. amiodarone, sotalol), anticoagulants, anti-platelet aggregating and/or beta-blockers. 12. active wounds or irritations in the area to be treated. 13. topical treatment with corticosteroids or other topical agent in the area to be studied.

Keywords: pain management lidocaine
cerebral oxygenation and neurological functioning after cardiac surgery

Conditions: Coronary Artery Disease; Cognitive Impairment; Delirium

Summary: the overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. the investigators aim to generate a timeline of neurological function that includes pre-existing performance, post-operative delirium, and neurological outcome. furthermore, the investigators will test the hypothesis that intraoperative regional cerebral oxygenation (rso2) desaturations, as measured by near-infrared spectroscopy (nirs) are associated with poor neurological functioning following cardiac surgery, as measured by a robotic device called the kinarm.


Eligibility criteria:
inclusion criteria: * adult patients undergoing coronary artery bypass surgery +/- valvular surgery exclusion criteria: * pre-existing cognitive impairment or neurodegenerative condition * any reason that participant cannot participate in follow up (lives too far away, limb amputation, speaks language other than english)
nationwide awareness campaign and call for dental screening for hht in germany

Conditions: Hereditary Hemorrhagic Telangiectasia; Dental Diseases

Summary: hht is a relative rare autosomal dominant inherited disorder of the fibrovascular tissue. diagnosis of hht is often delayed for decades (pierucci 2012). however, it would be desirable to achieve an early diagnosis as early screening and treatment decrease disease-associated complications and increase life expectancy (kroon 2018). our approach is a nationwide call and awareness campaign to dentists in germany, as nearly all persons visit a dentist from time to time. this approach is promising to us, as most patients develop nosebleeds and multiple, typical telangiectases of the skin or mucosa. a predilection site is the oral mucosa and the face, including the lips (shovlin 2000).

the german self-help group is taking down the number of inquiries from patients and physicians per months since april 2017. in june 2018 an article about hht is planned to be published in the journal of the german dental association and the federal association of fund dentists of germany. this journal is distributed to all dentists in germany and is a set book for them. total circulation in 2017 was 77,621 (http://www.aerzteverlag.de/portfolio/fachwissen-medizindental/zm-zahnaerztliche-mitteilungen/profil/ ). the article describes the case of visceral abscesses after dental screening in a patient with hht and pulmonary arteriovenous malformations. these could probably have been prevented if the dentist had prescribed an antibiotic prophylaxis to the patient. the article includes a call to search for telangiectases. if those are seen the dentist is recommended to ask the patient if he or relatives have nosebleeds. if both apply, the dentist is asked to inform the patient about hht and give him the address of the national german self-help group. after 3 and 6 months a reminder shall be published in the same journal.

Eligibility criteria:
inclusion criteria: * patients having telangiectasia and nosebleeds or nosebleeds in the family exclusion criteria: -

Keywords: pulmonary arteriovenous malformations
efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in chinese adults participants with paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Paroxysmal Nocturnal Hemoglobinuria; PNH

Summary: the primary objective of this study is to evaluate the efficacy of ravulizumab in adult participants with pnh.


Eligibility criteria:
inclusion criteria: * adult c5 inhibitor naive pnh patients (age\>=18), which is confirmed by flow cytometry evaluation. * must be vaccinated againast n meningitidis. exclusion criteria * meningitidis infection or unresolved meningococcal disease * history of bone marrow transplantation * other significant systemic diseases that might have impact on efficacy and safety assessment

Keywords: paroxysmal nocturnal hemoglobinuria pnh ravulizumab
comorbidities and education in spondyloarthritis study

Conditions: Axial Spondyloarthritis

Summary: giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic "environment". this study with its two parts should be able to demonstrate: * the importance of a systematic evaluation of comorbidities in spondyloarthritis, * the utility of a nurse-led program of self-assessment and self-management of the disease

patients with spondyloarthritis will be invited by their rheumatologists to participate at this study in 21 centers in france. 500 patients are planned to be included. after written informed consent will be obtained, the patients will be randomized in two arms: * comorbidities * self-assessment/self-management the patients will be seen again in the same center 12 months later in order to collect the outcome measures the two primary objectives of this trial are : * to evaluate the impact of a nurse led program of self-assessment of disease activity/severity and self-management on the level of satisfaction/coping * to evaluate the impact of a nurse led program of assessment of comorbidities on the management of such comorbidities the secondary objectives are: * to evaluate the prevalence of comorbidities in spa; * to evaluate the level of adherence to recommendations of prevention of comorbidities; * to evaluate the impact of the nurse led program of self-assessment / self-management on the amount of nsaid (non-steroidal anti-inflammatory drugs) intake and the level of disability (e.g. functional disability)

Eligibility criteria:
inclusion criteria: 1. male or female over 18 and under 80 years 2. axial spondyloarthritis according to the asas criteria (assessment of spondyloarthritis international society) 3. disease duration of at least one year 4. activity of spa to be stable according to the treating rheumatologist for at least three months before the date of inclusion 5. lack of elective surgery during the 6 months after inclusion 6. able to understand and adhere to the study treatments 7. development of a medical examination results given to the patient 8. informed consent signed and dated exclusion criteria: 1. pregnant women (any method of contraception will be accepted) 2. patients who have had a change in the treatment of spa during the 3 months prior to inclusion 3. history of alcoholism, drug addiction, psychological problems, severe comorbidities that could possibly invalidate informed consent or limit patient compliance with the study protocol 4. no affiliation to a social security regime -

Keywords: axial spondyloarthritis education co-morbidities nurse
autologous activated adipose-derived stem cells (rb-adsc) injected directly into the brain for mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: this is a research study to evaluate the safety of an investigational autologous cell product obtained from participant's own adipose tissue as a possible treatment for alzheimer disease.

this is a phase 1, open-label safety study of escalating doses of intracerebroventricular injections of ex vivo expanded, autologous adipose-derived stem cells (adscs) in participants with mild to moderate alzheimer's disease (ad) whose treatment is not addressed adequately by available therapy (i.e., an unmet medical need). the investigational product, which is referred to as rb-adsc, consists of stem cells obtained from the participant's own adipose tissue by lipoaspirate. after collection, the stem cells are cultured and expanded outside the body, and then reintroduced into the same patient. a soft plastic reservoir (ommaya reservoir) is implanted under the scalp, communicating with the brain cavities (ventricles). this study will primarily evaluate the safety of rb-adsc injected in the ommaya reservoir in a 3 + 3 dose escalation study. the planned enrollment will be 9 participants, 3 participants per escalation cohort. the primary objectives will evaluate adverse events, serious adverse events, and dose limiting toxicities to determine a recommended phase 2 clinical trial dose. secondary objectives will evaluate preliminary efficacy measured by clinical assessments, volumetric mri (neuro quant®), csf biomarkers (phospho-tau, total tau, ab-42), and diagnostic imaging comparison (amyloid pet). each participant will be followed for 12 months after treatment.

Eligibility criteria:
inclusion criteria: * ≥45 and ≤80 years of age * mild to moderate ad diagnosis * adequate cognitive function * non-remarkable clinical laboratory * ability to voluntarily provide written informed consent * no tumors or other disease responsible for dementia * well-controlled comorbidities, on stable medications for 3 months * the participant is otherwise in good general health * the participant must have a relative/caregiver * participant must be able to donate adequate amount of lipoaspirate to establish the final product * caregiver separately meets the specified inclusion/exclusion criteria for caregivers exclusion criteria: * taking other medications for ad, except that donepezil memantine, acheis including patches, vitamin e, fish oil, and/or gingko biloba are allowed if doses have been stable for at least 3 months prior to the screening visit * stem cell implantation of any type within 3 months * existing ventriculoperitoneal shunts * neurological disorders except ad * psychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, delirium * drug or alcohol abuse or dependence within the past 5 years * participants with a history of cancer in the past 5 years * no caregiver available to meet the inclusion criteria for caregivers

Keywords: alzheimer's disease ad autologous stem cells
effects of therapeutic exercise with elastic bands on strength and pain in women with non-specific neck pain.

Conditions: Neck Pain; Exercise Therapy; Women

Summary: the study consists of an intervention of 16 therapeutic exercise sessions during 8 weeks with a frequency of two sessions per week. all sessions had a practical focus (strength and stretching exercises) with the help of elastic bands. in addition, they had an initial session and another at the end of the intervention in which measurements of the different variables (cervical pain, cervical flexor strength, cervical extensor strength and strength of the scapular stabilising musculature) were taken on two occasions, at the beginning of the study and at the end of the intervention, an average of 2 months. nonspecific neck pain has a higher incidence in women than in men. female sex is a risk factor for this pathology. clinical practice guidelines highlight the importance of preventing neck pain through exercise. there are previous studies on the effects of strength programmes on patients with non-specific neck pain, but none have used elastic bands as an implement, despite the fact that it is one of the most commonly used implements in physiotherapy clinics. therefore, the aim of this study is to investigate the effects of an elastic band therapeutic exercise intervention in women with non-specific neck pain. it was previously hypothesised that this intervention would have positive effects on pain and strength in the cervical and scapular region.


Eligibility criteria:
inclusion criteria: * women. * 18-65 years of age. * with non-specific neck pain for at least three months, with pain intensity (30-70 on a vas). exclusion criteria: * any previous neck or shoulder surgery, fibromyalgia, cervical radiculopathy/myelopathy, history of the whiplash injury, cognitive disorder. * missing more than sessions. * not being able to attend the measurement sessions.
stroke adverse outcome is associated with nosocomial infections: pctus- guided antibacterial therapy in severe ischemic stroke patients (strawinski)

Conditions: Ischemic Stroke

Summary: development of stroke associated pneumonia (sap) has a detrimental effect on stroke outcome. biomarker-guided antibiotic treatment of patients at high risk for pneumonia may help to improve stroke outcome. therefore, the investigators will evaluate whether intensified infection monitoring via procalcitonin guiding an early standardized antibiotic treatment improves functional outcome after stroke compared with standard therapy based on current guidelines.


Eligibility criteria:
inclusion criteria: * age ≥18 years * stroke onset within the last 40 hours before randomisation * clinical diagnosis of a severe (nihss \> 9), non-lacunar stroke in the middle cerebral artery territory * consent given by the patient or by his/her legitimate representative where patients are incapable of giving consent themselves exclusion criteria: * ct evidence of an intracerebral haemorrhage or a lacunar infarct as the probable cause of the current illness * antibiotic use within the last 10 days * suspected life expectancy of \< 3 months * participation in other interventional trials (on pharmaceuticals or medical devices) * pregnancy, lactation * pre-stroke mrs score ≥ 4

Keywords: ischemic stroke stroke-associated infections biomarkers pct immune and infection parameters
antecolic versus retrocolic gastrojejunostomy during whipple's procedure

Conditions: Pancreatic Cancer Resectable; Pancreas Neoplasms

Summary: aim: this randomized clinical study aims to compare occurrence of dge in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy. methods: participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the surgical department of the university hospital of larissa. patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of dge will then be compared between the two groups. individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded. expected results: based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of dge, without a statistically significant difference between the two methods. we aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects dge.


Eligibility criteria:
inclusion criteria: * age over 18 years old * elective pancreaticoduodenectomy * signed consent form exclusion criteria: * age under 18 years old * patients who are participants in other trials that may affect the results of this study * patients who do not consent to participate in the study

Keywords: gastrojejunostomy whipple&#39;s antecolic retrocolic
study of fludarabine drug exposure in pediatric bone marrow transplantation

Conditions: Hematologic Malignancies; Nonmalignant Diseases; Immunodeficiencies; Hemoglobinopathies; Genetic Inborn Errors of Metabolism; Fanconi Anemia; Thalassemia; Sickle Cell Disease

Summary: fludarabine is a chemotherapy drug used extensively in bone marrow transplantation. the goal of this study is to determine what causes some children to have different drug concentrations of fludarabine in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. the hypothesis is that clinical and genetic factors cause changes in fludarabine drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.

fludarabine is a nucleoside analog with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric allogeneic hematopoietic cell transplantation (allohct) to promote stem cell engraftment. this is a single-center, pharmacokinetic-pharmacodynamic (pk-pd) study investigating the clinical pharmacology of fludarabine in 45 children undergoing allohct at university of california, san francisco benioff children's hospital. patients would receive fludarabine regardless of whether or not they decide to consent to pk sampling. fludarabine doses will not be adjusted based on pk data. we will apply the combination of a d-optimality-based limited sampling strategy and population pk methodologies to determine specific factors influencing fludarabine exposure in pediatric allohct recipients and identify exposure-response relationships. subjects will undergo pk sampling of plasma (f-ara-a) and intracellular (f-ara-atp) drug concentrations over the duration of fludarabine therapy (3 to 5 days). to evaluate sources of variability impacting fludarabine exposure clinical data will be obtained from the patient's medical chart on each day of pk sampling. a single blood draw for the collection of dna and genotyping of single nucleotide polymorphisms of genes involved in fludarabine activation, transport or elimination will occur in all patients. to assess exposure-response relationships neutrophil engraftment, treatment-related toxicity, and survival data will be collected through day 100 post-transplant.

Eligibility criteria:
inclusion criteria: * children 0-17 years of age * undergoing allohct for the treatment of malignant or nonmalignant disorder * receiving fludarabine-based preparative regimen exclusion criteria: * any child 7-17 years of age unwilling to provide assent * parent or guardian unwilling to provide written consent

Keywords: fludarabine pharmacokinetics pediatric allogeneic hematopoietic cell transplantation
effectiveness of sistertalk hartford for weight loss among african-american women

Conditions: Overweight; Obesity

Summary: the purpose of the sistertalk hartford study was to assess whether a theoretically- and scientifically-based, culturally acceptable weight loss program could be effectively translated into a faith-based program and subsequently delivered in the church to help african-american women lose weight.


Eligibility criteria:
inclusion criteria: * bmi of at least 25.0 * self-identifies as black or african-american * able to do mild physical activity such as walking or chair exercises exclusion criteria: * has insulin dependent diabetes * is pregnant, nursing, or had a baby in the past 4 months * has ever been treated for an eating disorder (e.g. anorexia nervosa, bulimia) * had a heart attack in the past 2 years requiring hospitalization * has ever had a stroke * has congestive heart failure * has uncontrolled hypertension * currently participating in another study * is on a doctor-prescribed diet that cannot be changed (e.g. very low protein diet for a person in liver failure)

Keywords: overweight obesity african american women translational faith based community based participatory research
clinical outcomes of edwards lifesciences mitris reslila mitral valve in the asian population

Conditions: Mitral Valve Insufficiency

Summary: the purpose of this study is to evaluate the early and mid-term safety and performance of the mitris resilia mitral valve in asian patients in a real-world setting

this study is a prospective, investigator-investigator initiated, multicenter observational study that aims to competitively register 200 patients who have undergone mitral valve replacement surgery with the mitris resilia mitral valve at participating institutions to collect real clinical outcomes. this study will collect data on clinical outcomes obtained during standard care for patients who undergo mitral valve replacement surgery using the mitris resilia mitral valve in south korea. the aim is to recruit 200 patients using the mitris resilia mitral valve (competitive recruitment, no more than 100 per institution) over a period of two years. all patients registered in the registry will be followed for five years. follow-up assessments will occur at 6 months, 1 year, 2 years, 3 years, and 5 years post-surgery. including the 2-year registration period and 5 years of follow-up for result analysis, the total study duration is expected to be approximately 7.5 years. however, the overall duration may vary depending on the rate of participant registration.

Eligibility criteria:
inclusion criteria: 1. age 19 or older 2. requires mitral valve replacement due to mitral valve dysfunction 3. the participant or their guardian can provide a written consent form approved by the irb and agree to the research protocol and clinical follow-up schedule. exclusion criteria: 1. life expectancy of less than one year due to causes other than cardiovascular disease 2. high-risk candidates for mitral valve replacement: society of thoracic surgeons predicted risk of mortality 10% or greater; euroscore 10% or greater; estimated surgical mortality rate by the surgeon 10% or greater 3. chronic kidney disease: egfr \<30 ml/min/1.73m² 4. undergoing surgery for infective endocarditis

Keywords: mitral valve replacement
retrospective pns study

Conditions: Chronic Pain

Summary: retrospective pns study


Eligibility criteria:
inclusion criteria: a. subjects are at least 18 years of age, b. subjects have been diagnosed with refractory chronic pain, c. subject has been implanted with a permanent freedom peripheral nerve stimulation system. exclusion criteria: a. any additional active implanted devices for the treatment of chronic pain in addition to the freedom peripheral nerve stimulation system.

Keywords: retrospective, chronic pain, pns